Aimovig And Tegsedi In Raft Of Products To Get EMA Thumbs up
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A handful of companies are expected to find out this week whether their products will be recommended for EU approval. The EMA's drug evaluation committee, the CHMP, is due to give its opinion on marketing authorization on two orphan drugs for use in HAE and myotonia respectively, another biosimilar trastuzumab, and a flu vaccine.
Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.
European approval is in the bag for Onpattro for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis but in a week where ICER has criticized the price of the RNAi drug in the US, Alnylam now has to navigate reimbursement talks on this side of the Atlantic.